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Summary

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.

Table of Contents

PREFACEACKNOWLEDGMENTSFOREWORD

INTRODUCTION

THE TRANSFORMATION IN THE EUROPEAN COMMUNITY

THE CURRENT SITUATION-THE EC MEDICAL DEVICE DIRECTIVE

THE CURRENT SITUATION-REGULATIONS IN USA AND JAPANA Comparison with the Medical Devices Directive

THE CURRENT SITUATION-REGULATORY DEVELOPMENTS IN OTHER COUNTRIES

THE PLACE OF QUALITY SYSTEMS

THE USE OF PRODUCT STANDARDS

THE QUESTION OF EFFECTIVENESS

POST-MARKET CONTROLS

PROPOSALS AND PROSPECTS FOR A GLOBAL REGULATORY SYSTEM FOR MEDICAL DEVICES

OVERVIEW AND LOOK TO THE FUTURE

APPENDICES REFERENCESBIBLIOGRAPHY

Reviews

"This book provides a good overview of the existing regulations within the principle areas without becoming bogged down in the details of those regulations … it is a good compilation of the existing state of regulatory affairs concerning medical devices in general. The author did an excellent job in comparing and contrasting the various regulations and regulatory rationales."-James G. Yusko, Health Physics

"Unlike the various papers which have been published previously, this book gives a fair and unbiased comparison of the strengths and weaknesses of various approaches. The overall result is an informed text written with a firm conviction that things are heading in the right direction and a clear vision of what that direction is … This book is an essential read for anyone involved with the design, marketing, or regulatory affairs aspects of medical devices. It should be in the library of all medical device regulators and manufacturers (including university and hospital clinical engineering departments)."-W. J. O'Dowd, Physics in Medicine & Biology